—#204967

Product

Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K183647
Affected lot / code info: Lot Number: All units sold prior to 2023

Why it was recalled

The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An URGENT: MEDICAL DEVICE REMOVAL notification letter dated 12/4/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has received one or more affected units. Olympus requests you to take the following actions: 1. Examine your inventory and quarantine any devices with the lot number specified above. 2. Please contact Olympus customer service representative at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0435 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including product labeling issues, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide. Global Distribution

Timeline

Recall initiated: 2023-12-04
Posted by FDA: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204967. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.